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Found 20079 cases where Vaccine is PNC13

Case Details (Reverse Sorted by Appearance Date)

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VAERS ID:656879 (history)  Vaccinated:2016-09-30
Age:1.0  Onset:2016-09-30, Days after vaccination: 0
Gender:Female  Submitted:2016-10-03, Days after onset: 3
Location:Unknown  Entered:2016-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURC4916AA3IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHL992593IMRL
Administered by: Unknown     Purchased by: Public
Symptoms: Peripheral swelling, Swelling face, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hives over entire body; hand, feet and face swelling a few hours after the vaccines were given.

VAERS ID:656889 (history)  Vaccinated:2016-09-29
Age:46.0  Onset:2016-09-30, Days after vaccination: 1
Gender:Female  Submitted:2016-10-03, Days after onset: 3
Location:Oregon  Entered:2016-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN165150IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Headache, fever, redness/pain/swelling at injection site.

VAERS ID:656891 (history)  Vaccinated:2016-10-01
Age:60.0  Onset:2016-10-02, Days after vaccination: 1
Gender:Female  Submitted:2016-10-03, Days after onset: 1
Location:South Carolina  Entered:2016-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: No known allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT)GLAXOSMITHKLINE BIOLOGICALSJ97D20IMLA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN165600IMRA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.L0355060SCLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness, discomfort, warm feeling in area of injection approximately 2 inches wide.

VAERS ID:657309 (history)  Vaccinated:2016-09-16
Age:69.0  Onset:2016-09-20, Days after vaccination: 4
Gender:Female  Submitted:2016-10-03, Days after onset: 13
Location:New York  Entered:2016-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURUI672AB0IMRA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN165610IMLA
Administered by: Other     Purchased by: Private
Symptoms: Abdominal pain upper, Cellulitis, Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Received PREVNAR-13 and FLUZONE HD on 9/16/16 in separate arms. Stated she had a low grade fever, stomach ache, headache for 2 days afterwards, then on 4th day after her injection site where PREVNAR-13 was given because red/swollen/warm. Went to MD and diagnosed with cellulitis. Given KEFLEX 500mg twice daily.

VAERS ID:657337 (history)  Vaccinated:2016-09-19
Age:1.0  Onset:2016-09-28, Days after vaccination: 9
Gender:Female  Submitted:2016-10-03, Days after onset: 5
Location:Missouri  Entered:2016-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Vibratory heart (M) at 12 mo of age
Diagnostic Lab Data: On exam
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUT5583JA0IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.M0162340SCLA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN165603IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.M0233810SCRA
Administered by: Private     Purchased by: Private
Symptoms: Irritability, Nasopharyngitis, Otitis media, Pyrexia, Rash, Rash morbilliform, Viral rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Rec''d 12 mo imm. 9/19/16 at office during 12 mo. WCE. Seen 9/30/16 for reported s/s: morbilliform rash (pink) to scalp, neck, trunk and ext. began 9/28/16. Increased fussiness and ''cold s/s'' x approximately 2 wks. Tactile fever 9/28 and 9/29/16 eve''s. Dx = viral exanthem secondary MMR vac. and BSOM. Observation - PRN Ab if fever or ear pulling next 1-2 days.

VAERS ID:658423 (history)  Vaccinated:2016-09-30
Age:0.75  Onset:2016-10-02, Days after vaccination: 2
Gender:Male  Submitted:2016-10-03, Days after onset: 1
Location:Arizona  Entered:2016-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSC5090AA UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHM60994 UNRL
Administered by: Private     Purchased by: Public
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash.

VAERS ID:658426 (history)  Vaccinated:2016-07-29
Age:71.0  Onset:2016-07-30, Days after vaccination: 1
Gender:Male  Submitted:2016-09-27, Days after onset: 59
Location:Florida  Entered:2016-10-03, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Spondylolisthesis, L4, 5, S1
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Joint injection, Skin lesion
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 7/7/16 Vaccine negated effects of recent lesi and hip steroid injection. (7/21/16).

VAERS ID:658428 (history)  Vaccinated:2016-09-09
Age:0.17  Onset:2016-09-13, Days after vaccination: 4
Gender:Male  Submitted:2016-09-19, Days after onset: 6
Location:Connecticut  Entered:2016-10-03, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ranitidine
Current Illness:
Preexisting Conditions: Milk protein allergy; Enteocolitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC5088AA0IMLA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHM989160IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.M0045420PO 
Administered by: Private     Purchased by: Public
Symptoms: Haematochezia, Irritability
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Ischaemic colitis (broad), Hypoglycaemia (broad)
Write-up: Crankiness and gross blood in stools.

VAERS ID:658469 (history)  Vaccinated:2016-09-26
Age:0.17  Onset:0000-00-00
Gender:Male  Submitted:2016-09-30
Location:Michigan  Entered:2016-10-03, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS4233K IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.M020102 IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHM13067 IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CB564A PO 
Administered by: Private     Purchased by: Private
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:, Medication errors (narrow)
Write-up: No adverse event.

VAERS ID:658470 (history)  Vaccinated:2016-05-16
Age:58.0  Onset:2016-05-18, Days after vaccination: 2
Gender:Female  Submitted:2016-10-03, Days after onset: 138
Location:Texas  Entered:2016-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHM77339 UNLA
Administered by: Military     Purchased by: Military
Symptoms: Oedema, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: LLR following PREVNAR 13 - adult, 10 x 13 cm edema and tenderness.

VAERS ID:658471 (history)  Vaccinated:2016-09-30
Age:65.0  Onset:2016-09-30, Days after vaccination: 0
Gender:Female  Submitted:2016-10-03, Days after onset: 3
Location:Idaho  Entered:2016-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN165620IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal discomfort, Constipation, Fatigue, Headache, Malaise, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Severe, fatigue, headache, sore arm, upset stomach and nausea, constipation. Began 2hrs after shot and is still sick 3 days after.

VAERS ID:658473 (history)  Vaccinated:2016-03-28
Age:65.0  Onset:2016-06-23, Days after vaccination: 87
Gender:Male  Submitted:2016-09-23, Days after onset: 92
Location:Alabama  Entered:2016-10-03, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole; Meloxicam
Current Illness: Chronic sinusitis; GERD
Preexisting Conditions: PCN (hypertension); Codeine (anxiety)
Diagnostic Lab Data: AiC 7/14/16 = 6.0 not DM MRI 9/6/16 (L) shoulder and have cellulitis tendonitis and tendonopathy pending NCV
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHM032110IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia oral
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: As of June 23, 2016 (L) arm pain starting in area of injection progressive pain to reach shoulder, elbow (L) arm (L) hand and (R) too, paresthesia lips on and off no change by stopping meloxicam.

VAERS ID:658479 (history)  Vaccinated:2016-09-07
Age:53.0  Onset:0000-00-00
Gender:Female  Submitted:2016-09-27
Location:New York  Entered:2016-10-03, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin; LIPITOR; LOTENSIN; PLAVIX; PEPCID; HCTZ, SYNTHROID
Current Illness: None
Preexisting Conditions: Allergy to IV dye
Diagnostic Lab Data: CMP
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHM989150IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Metabolic function test, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient presents to the clinic with erythematous patch on left arm just below injection site, left upper arm noticed to be longer than the right and c/o low grade fever for 6 days, body aches.

VAERS ID:658856 (history)  Vaccinated:2016-09-25
Age:86.0  Onset:2016-09-26, Days after vaccination: 1
Gender:Female  Submitted:2016-10-03, Days after onset: 7
Location:Connecticut  Entered:2016-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN16515 IMAR
Administered by: Unknown     Purchased by: Other
Symptoms: Erythema, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness. Swelling. Hot warmth on arm.

VAERS ID:656645 (history)  Vaccinated:2013-10-11
Age:0.4  Onset:2016-03-06, Days after vaccination: 877
Gender:Male  Submitted:2016-10-03, Days after onset: 210
Location:Foreign  Entered:2016-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aluminum compounds
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: DKSA2016SA146481
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIPV: DTP + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER 2IMLG
HIBV: HIB (ACTHIB)SANOFI PASTEUR 2IMLG
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergy to metals, Asthma, Eczema, Hair growth abnormal, Injection site erythema, Injection site pruritus, Pruritus, Reaction to drug excipients, Skin wound, Sleep disorder, Vaccination site granuloma, Vaccination site haemorrhage, Vaccination site reaction, Vaccination site scar
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Based on additional information received on 23-Sep-2016, this case was upgraded to serious due to the other medically important condition asthmatic bronchitis. Initial unsolicited case received from SPMSD under reference number: 2016008099. Case received from a physician via Health Authority and other Company SSI on 22-Jul-2016 under the reference number DK-DKMA-WBS-0004011 and DKSSI0111627. A 5-month-old male infant patient received Act-Hib, (batch number H8099-2, Dose 1) via intramuscular route in Thigh site on 02-Jan-2013, Act-Hib, (batch number Lot unknown, Dose 2) via intramuscular route in Thigh site on 08-Mar-2013, Act-Hib, (batch number Lot unknown, Dose 3) via intramuscular route in Thigh site on 11-Oct-2013. Other suspect products included: Ditekipol, (batch number 0134A, Dose 1) administered via intramuscular route in Thigh site on 02-Jan-2013, Ditekipol, (batch number LOT UNKNOWN, Dose 2) administered via intramuscular route in Thigh site on 08-Mar-2013, Ditekipol, (batch number LOT UNKNOWN, Dose 3) administered via intramuscular route in Thigh site on 11-Oct-2013, Aluminium Compounds, (batch number unknown) on an unknown date. The patient received concomitant administration of PREVENAR 13 1DF on 11-Oct-2013. The patient experienced Vaccination site granuloma on 6-Mar-2016, aluminium allergy, reaction to drug excipient and severe itch on an unknown date. Event description: Had a severely itching vaccination granuloma for a very long time. According to the parents, he has developed aluminium allergy. No other medications. Comments from regulatory authority: Regulatory authority has contacted the GP and received batch numbers for PREVENAR 13. For DiTeKiPol/Act-Hib, the full batch number has been possible to retrieve only for the 1st vaccination. It has not been possible to obtain the administration route for PREVENAR 13 or information of which thigh each vaccine was given in. The patient''s outcome was reported as Not Recovered/Not Resolved. Follow up received from Patient Insurance Company (PIC) via SSI case no 16-6932 on 23-Sep-2016: The case has been upgraded to serious due to the other medically important condition asthmatic bronchitis. The parent has applied for compensation on behalf of the son since he, after participating in the Childhood Vaccination Program, has developed itching granulomas on both thighs. The parent informs: that the patient has granulomas on both thighs, that he scratches on the granulomas, that he sometimes scratches until bleeding on the vaccination areas, that he has disturbed nocturnal sleep due to the pruritus, that he has increased hair growth on the vaccination area, that he has scar tissue around the vaccination area, that he has eczema and asthmatic bronchitis. Attached photos of the patient''s thighs shows redness, scratch marks and increased hair growth. The patient has in connection to the problems been examined by GP. According to the vaccination card the patient was vaccinated with Ditekipol/Act-hib and PREVENAR on 02Jan2013, 08Mar2013 and 11Oct2013. During telephone consultation on 05Mar2014 with the pediatric clinic the parent was informed that the granulomas was not dangerous but that they could be present and cause problems up to several years. On 13May2016 the patient was examined by the GP. According to the medical records the physician would report the adverse events to regulatory authority. Justification: PIC has assessed that the granulomas on the patient''s thighs are most likely a consequence of vaccination with either Ditekipol/Act-hib or PREVENAR 13. In the Decision PIC has emphasized that: Both vaccines contains aluminium, Granulomas, allergy to aluminium and pruritus are known but rare adverse events to these vaccines, The problems developed in the same area as the vaccines were given. The patient is therefore entitled to compensation. PIC has furthermore assessed that it is unlikely that the patient''s eczema and asthmatic bronchitis are consequences of the alumi

VAERS ID:656647 (history)  Vaccinated:2016-09-23
Age:0.3  Onset:2016-09-23, Days after vaccination: 0
Gender:Male  Submitted:2016-10-03, Days after onset: 10
Location:Foreign  Entered:2016-10-03
Life Threatening? Yes
Died? Yes
   Date died: 2016-09-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Diagnostic Lab Data:
CDC Split Type: JPSA2016SA179079
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIPV: DTP + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER4K16B1SCUN
HIBV: HIB (ACTHIB)SANOFI PASTEURL16492SCRA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH15J01A2SCRA
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.L0310172PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Intensive care, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)
Write-up: Initial unsolicited report received from a physician via authority (under Reference number: V16100489) on 27 Sep 2016. This case involves a 04-month-old male patient who was vaccinated with 0.5 ml third dose of ACTHIB (batch number: L1649) via subcutaneous route in right arm (extensor surface of the right upper arm); with 0.5 ml third dose of PREVENAR13 (batch number: 15J01A) via subcutaneous route in right arm (extensor surface of the right upper arm); with 0.5 ml second primary dose of DPT-IPV (batch number: 4K16B, expiry date, 13-Apr-2018) via subcutaneous route; with 2 ml third primary dose of ROTATEQ ORAL SOLUTION (batch number: L031017) via oral route on 23 Sep 2016 at around 15:40 hour. The patient''s medical history and family history included abnormal findings at delivery, abnormal findings after birth, abnormality identified at an infant health check, physical deconditioning on the day of the vaccination, disease within 1 month before the vaccination, consultation with a physician for congenital anomaly, heart, kidney, liver, central nerve disease, immune deficiency, or any other diseases, history of seizure (convulsion), history of rash, urticaria, or physical deconditioning due to drugs or food, history of deconditioning due to a vaccine, history of a blood transfusion or gamma globulin injection within 6 months before the vaccination, family history, family member or friend of the patient having measles, rubella, varicella or mumps within 1 month before the vaccination, family member or relative with a congenital immunodeficiency, history of deconditioning due to a vaccine in family member or relative was reported as none. The patient previously vaccinated with a dose of PNEUMOCOCCAL CONJUGATE VACCINE (PCV) and ROTAVIRUS VACCINE on 26 August 2016. The body temperature before the vaccination was 37.0 Degree Celsius. Concomitant medications were not reported. It was reported that, the patient'' guardian had read and understood the written instruction for the vaccination, and had no question for the vaccination on 26 August 2016. Feeding was favorable and his condition, feeding was favorable and his condition on the day. On 23 Sep 2016, at 19:49 hours, 4 hours 9 minutes following the vaccination, the patient was found lying face down and in a state of respiratory arrest. Same day, an ambulance was called, he was transported to another hospital and was admitted to the PICU of the hospital on the day. The patient previously vaccinated with a dose of PNEUMOCOCCAL CONJUGATE VACCINE (PCV); with a dose of HIB (PRP/T) VACCINE (ACTHIB); with a dose of DIPHTHERIA/TETANUS/2 AC PERTUSSIS/IPV (VERO) VACCINE (DPT-IPV) on 26 August 2016. The patient''s laboratory data was not reported. The patient underwent cardiopulmonary resuscitation on 23 Sep 2016. The outcome of event was not reported. Diagnosis: Cardio-respiratory arrest. Reporting physician''s seriousness assessment: Serious (Life-threatening, Hospitalization or prolongation of hospitalization, medically significant). Reporting physician''s causality assessment: Unknown Reporting physician''s comment: Another possible causative factor for the event was asphyxia due to lying face down. Sudden infant death syndrome (SIDS) was considered possible. List of documents held by sender: none. Sender''s Comments: The evening post-third dose of the primary vaccination (ActHIB, pneumococcal conjugate, DTaP-IPV and Rotavirus simultaneous vaccines), this infant boy was found lying down and in a state of respiratory arrest (onset of "cardio-respiratory arrest") and apparently died despite cardiorespiratory resuscitation. SIDS or death as per asphyxia were evoked. No autopsy results were provided. Although, the time to onset is compatible, also multiple vaccines were simultaneously administered hence the role of each vaccine component cannot be assessed.

VAERS ID:656695 (history)  Vaccinated:0000-00-00
Age:  Onset:0000-00-00
Gender:Male  Submitted:2016-10-03
Location:Foreign  Entered:2016-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2016450972
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
MENB: MENINGOCOCCAL B (BEXSERO)NOVARTIS VACCINES AND DIAGNOSTICS 1UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 1UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Erythema, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This is a spontaneous report received from a contactable healthcare professional via the Regulatory Agency. Regulatory authority report number GB-MHRA-ADR 23654270. A child male patient received a single dose of PREVENAR 13, BEXSERO intramuscularly, ROTARIX orally and INFANRIX IPV HIB all on an unknown date for vaccination. The patient medical history was not reported. Concomitant medication included paracetamol at 2.5 ml. On an unknown date, the patient experienced high temperature, redness and breathing difficult. The child received first vaccinations as per schedule. The parent gave the baby the paracetamol regime, first dose straight after vaccines and second dose 4-6 hours after, but 2 hours after this second dose, the baby had very high temperature, went very red and had breathing difficulties. The patient was admitted to the hospital and given intravenous antibiotics. He was discharged when the temperature returned to normal. The reporter stated 2.5ml paracetamol was not enough as this was a big baby. High temperature recovered on an unknown date; the outcome of redness and breathing difficult was unknown. The reporter considered the case to be serious as the events were medically significant and the regulatory authority considered the case to be serious for an unspecified reason. No follow-up attempts possible. No further information expected.

VAERS ID:656696 (history)  Vaccinated:2015-05-12
Age:0.33  Onset:2015-05-13, Days after vaccination: 1
Gender:Female  Submitted:2016-10-03, Days after onset: 509
Location:Foreign  Entered:2016-10-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2016454792
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHL391191UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cerebrovascular accident, Facial asymmetry, Hypotonia, Mobility decreased, Muscular weakness, Neurological symptom, Posture abnormal, Staring, Unresponsive to stimuli
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: This is a spontaneous report from a contactable other HCP. This is a report received from the Ministry of Health. Regulatory authority report number not provided. A 4-month-old female patient was vaccinated with PREVENAR 13, (lot # L39119) 2nd single dose, ROTATEQ at an unspecified dose and PEDIACEL at an unspecified dose, all via an unspecified route of administration on 12May2015 for immunisation. The patient medical history and concomitant medications were not reported. One day after vaccine administration, the mother noticed that her daughter was with a fixed gaze to the right side and lack of response to vocal stimulus on the left side. On 13May2016 she was hospitalized with neurological symptoms without fever increase. The baby girl was discharged on 20May2015 with a diagnosis of right occipital stroke, on her discharge she received recommendations for medicinal treatment for convulsions and recommendations for check-ups continuation, an invitation to day hospitalization (outpatient clinic) and follow-up at the child''s development institute. In an update received on 26Jul2016 the baby girl was under a neurological follow-up, furthermore she was visiting once a week at the physical therapy institution. Her state was improving a little, there was still a weak tone, sloping head, loose left hand and thumb. In a follow-up examination performed on 26Nov2015 the baby girl was in a better condition excluding gentle asymmetry of the face on the left and the relatively small involvement of left leg while crawling. As far as it was known she was under follow-up and treatment at the child''s development institute.

VAERS ID:674266 (history)  Vaccinated:0000-00-00
Age:  Onset:0000-00-00
Gender:Male  Submitted:2016-09-30
Location:Foreign  Entered:2016-10-03, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Paracetamol
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: On an unknown date the patient''s body temperature was "High".
CDC Split Type: GB2016140480
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
MENB: MENINGOCOCCAL B (BEXSERO)NOVARTIS VACCINES AND DIAGNOSTICS 0IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 0UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Erythema, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of high temperature in a male patient who received BEXSERO. Co-suspect products included ROTARIX, INFANRIX-IPV-HIB and PREVENAR 13. Concomitant products included paracetamol. On an unknown date, the patient receive the 1st dose of BEXSERO (intramuscular), the 1st dose of ROTARIX (oral), the 1st dose of INFANRIX-IPV-HIB (unknown) and the 1st dose of PREVENAR 13 (unknown). On an unknown date, several hours after receiving BEXSERO, ROTARIX and INFANRIX-IPV-HIB and an unknown time after receiving PREVENAR 13, the patient experienced high temperature (serious criteria other), redness (serious criteria other) and breathing difficult (serious criteria other). On an unknown date, the outcome of the high temperature was recovered/resolved and the outcome of the redness and breathing difficult were unknown. It was unknown if the reporter considered the high temperature, redness and breathing difficult to be related to BEXSERO, ROTARIX and INFANRIX-IPV-HIB. Additional information: Age at vaccination was not provided. Regulatory Authority verbatim: Child received first vaccinations as per schedule. Parent gave the baby the paracetamol regime, first dose straight after vaccines, second dose 4-6 hours after but 2 hours after this second dose baby had very high temperature, went very red and had breathing difficulties. Mum rang 111 as per advice given at surgery, they sent ambulance, admitted and given intravenous antibiotics. Discharged when temperature returned to normal. I think the 2.5ml paracetamol was not enough as this was a big baby.

VAERS ID:674284 (history)  Vaccinated:2016-08-17
Age:0.2  Onset:2016-08-17, Days after vaccination: 0
Gender:Male  Submitted:2016-09-30, Days after onset: 44
Location:Foreign  Entered:2016-10-03, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 08/17/2016, Body temperature, 39.3
CDC Split Type: GB2016140477
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
MENB: MENINGOCOCCAL B (BEXSERO)NOVARTIS VACCINES AND DIAGNOSTICS  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Feeling hot, Pyrexia, Somnolence
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of high temperature in a 2-month-old male patient who received BEXSERO. Co-suspect products included INFANRIX-IPV-HIB, ROTARIX and PREVENAR 13. On 17th August 2016, the patient received BEXSERO (unknown) 1 dosage form, INFANRIX-IPV-HIB (unknown), ROTARIX (unknown) and PREVENAR 13 (unknown). On 17 August 2016, several hours after receiving BEXSERO, INFANRIX-IPV-HIB and ROTARIX, the patient experienced high temperature (serious criteria other), labored breathing (serious criteria other), sleepy (serious criteria other) and feeling hot (serious criteria other). On an unknown date, the outcome of the high temperature, labored breathing, sleepy and feeling hot were recovered/resolved. It was unknown if the reporter considered the high temperature, labored breathing, sleepy and feeling hot to be related to BEXSERO, INFANRIX-IPV-HIB and ROTARIX. Regulatory Authority Verbatim: On the day of the vaccination, later in the evening reactions occurred. Temperature of 39.3, breathing heavy, hot, sleepy. Called 999 as 111 took too long to call back. Paracetamol (2 doses) given as treatment. Given paracetamol at home. Not admitted to hospital.

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